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COMPARISON OF PHARMACOKINETICS AND PHARMACODYNAMICS OF THE ORIGINAL AND GENERIC ENALAPRIL IN THE ELDERLY PATIENTS WITH ARTERIAL HYPERTENSION

https://doi.org/10.20996/1819-6446-2012-8-2-149-153

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Abstract

Aim. To study the pharmacokinetic, pharmacodynamic and pharmacoeconomic parameters of the original and generic enalaprils in the treatment of the elderly patients with hypertension (HT). Material and Methods. Patients (n=40) 75–90 years with HT were included in the open randomized comparative study. Patients were randomized into two groups. Patients of the group 1 received generic enalapril, patients of the group 2 — the original enalapril consisting of combined therapy. Pharmacokinetic single-dose study of original and generic enalapril were carried out with high-performance liquid chromatography. Pharmacodynamic study was carried out in single-dose administration as well as after 2 and 4 weeks of treatment with original and generic enalapril. Pharmacoeconomic evaluation of antihypertensive drugs was carried out on the basis of cost minimization analysis. Results. Original enalapril dose necessary to achieve the target blood pressure (BP) was 10 mg/day as a part of two-component therapy. This for generic enalapril was 20 mg/day consisting of three- or four-component therapy. Both drugs have shown an acceptable safety profile. Pharmacokinetic differences were revealed between original and generic enalapril: area under pharmacokinetic curve 204.14 (202.25–206.05) vs 136.23 (134.17–137.65) ng*h/ml, respectively; time of the drug retention in the blood plasma 5.42 (5.26–5.76) vs 4.88 (4.86–4.94) hours, respectively; p<0.001. Original enalapril demonstrated more stable 24-hour antihypertensive effect in once daily administration in comparison with this in generic enalapril: trough/peak ratio 78.67% (47.61–91.35%) vs 44.96% (32.44–55.49%), respectively , p<0.01. The average daily cost of combined therapy containing generic enalapril was 15.91 rubles per patient, while this in combined therapy containing original enalapril — 13.78 rubles per patient. Conclusion. Medicines on the basis of original and generic enalapril have pharmacokinetic, pharmacodynamic and pharmacoeconomic differences.

About the Authors

O. P. Bobrova
Krasnoyarsk State Medical University named after V.F . Voyno-Yasenetsky Krasnoyarsk Regional Hospital for War Veterans
Russian Federation


M. M. Petrova
Krasnoyarsk State Medical University named after V.F . Voyno-Yasenetsky
Russian Federation


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For citation:


Bobrova O.P., Petrova M.M. COMPARISON OF PHARMACOKINETICS AND PHARMACODYNAMICS OF THE ORIGINAL AND GENERIC ENALAPRIL IN THE ELDERLY PATIENTS WITH ARTERIAL HYPERTENSION. Rational Pharmacotherapy in Cardiology. 2012;8(2):149-153. (In Russ.) https://doi.org/10.20996/1819-6446-2012-8-2-149-153

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ISSN 1819-6446 (Print)
ISSN 2225-3653 (Online)